Botensilimab
drugOn this page
Also known as AGEN-1181Agen1181
Summary
Botensilimab (CHEMBL4650435) is a phase-3 clinical-stage antibody; indicated across 10 conditions including melanoma and colorectal neoplasm.
At a glance
- Status: Max clinical phase 3 (not approved)
- Modality: Antibody
- Indications: 10 conditions
- Clinical trials: 37
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL4650435 |
| Name | Botensilimab |
| Type | Antibody |
| Max phase | 3 |
Also known as: AGEN-1181, Agen1181, AGEN1181, Botensilimab, BOTENSILIMAB
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
10 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| melanoma | 2 | MONDO:0005105 | EFO:0000756 |
| colorectal neoplasm | 2 | MONDO:0005335 | EFO:0004142 |
| renal cell carcinoma | 2 | MONDO:0005086 | EFO:0000681 |
| neoplasm | 1 | MONDO:0005070 | EFO:0000616 |
| non-small cell lung carcinoma | 1 | MONDO:0005233 | EFO:0003060 |
| angiosarcoma | 1 | MONDO:0016982 | EFO:0003968 |
| ovarian cancer | 1 | MONDO:0008170 | MONDO:0008170 |
| endometrium neoplasm | 1 | MONDO:0021251 | MONDO:0011962 |
2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 37.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 23 |
| PHASE1 | 6 |
| PHASE3 | 2 |
| PHASE1/PHASE2 | 2 |
| EARLY_PHASE1 | 2 |
| PHASE2/PHASE3 | 1 |
| Not specified | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT06279130 | PHASE2/PHASE3 | RECRUITING | Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations |
| NCT06346197 | PHASE3 | RECRUITING | Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas |
| NCT07152821 | PHASE3 | RECRUITING | Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma |
| NCT04028063 | PHASE2 | ACTIVE_NOT_RECRUITING | Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas |
| NCT05529316 | PHASE2 | ACTIVE_NOT_RECRUITING | A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma |
| NCT05571293 | PHASE2 | ACTIVE_NOT_RECRUITING | Combination Immunotherapy in Colorectal Cancer |
| NCT05608044 | PHASE2 | ACTIVE_NOT_RECRUITING | A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer |
| NCT05627635 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metastatic Colorectal Cancer |
| NCT05630183 | PHASE2 | ACTIVE_NOT_RECRUITING | A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer |
| NCT05632328 | PHASE2 | ACTIVE_NOT_RECRUITING | AGEN1423 and Botensilimab w/ or w/o Chemo in PDAC |
| NCT05672316 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy |
| NCT05845450 | PHASE2 | RECRUITING | Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN) |
| NCT05864534 | PHASE2 | RECRUITING | Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma |
| NCT06251973 | PHASE2 | ACTIVE_NOT_RECRUITING | A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer |
| NCT06268015 | PHASE2 | ACTIVE_NOT_RECRUITING | Botensilimab and Balstilimab Optimization in Colorectal Cancer |
| NCT06300463 | PHASE2 | RECRUITING | Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases |
| NCT06322108 | PHASE2 | RECRUITING | Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008) |
| NCT06780787 | PHASE2 | RECRUITING | FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery |
| NCT06843434 | PHASE2 | RECRUITING | A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma |
| NCT06843551 | PHASE2 | RECRUITING | The Miami EMPIRE Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation |
| NCT07227636 | PHASE2 | RECRUITING | A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy |
| NCT07516366 | PHASE2 | NOT_YET_RECRUITING | Testing the Safety and Feasibility of Immunotherapy Drugs, Botensilimab and Balstilimab, Before Surgery for Clear Cell Renal Cell Carcinoma, NEO RoBOT Trial |
| NCT07550088 | PHASE2 | NOT_YET_RECRUITING | BAL/BOT/agenT-797 in pMMR CRC With Liver Metastases |
| NCT07551596 | PHASE2 | NOT_YET_RECRUITING | Testing the Combination of Anti-Cancer Drugs, Botensilimab (AGEN1181) and Balstilimab (AGEN2034), After Standard Treatment for Colorectal Cancer, Combat Trial |
| NCT07578337 | PHASE2 | NOT_YET_RECRUITING | A Clinical Study Evaluating a New Treatment Strategy for Patients With Advanced Pancreatic Cancer Who Have Not Received Prior Treatment for Advanced Disease. |
| NCT07595874 | PHASE2 | NOT_YET_RECRUITING | Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer NEST3 |
| NCT05928806 | PHASE2 | SUSPENDED | Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial |
| NCT06575725 | PHASE2 | WITHDRAWN | Botensilimab, Balstilimab and Regorafenib or Botensilimab and Balstilimab for the Treatment of Advanced or Metastatic Microsatellite Stable Colorectal Cancer |
| NCT03860272 | PHASE1 | ACTIVE_NOT_RECRUITING | Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer |
| NCT06076837 | PHASE1 | ACTIVE_NOT_RECRUITING | The Seven Trial: Exploiting the Unfolded Protein Response |
| NCT06336902 | PHASE1 | RECRUITING | Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer |
| NCT06411691 | PHASE1 | RECRUITING | KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer |
| NCT04121676 | PHASE1 | COMPLETED | Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer |
| NCT05377528 | PHASE1 | COMPLETED | Study of AGEN1571 in Participants With Advanced Solid Tumors |
| NCT07128355 | EARLY_PHASE1 | RECRUITING | Botensilimab, Balstilimab, and SBRT in Colorectal Cancer |
| NCT07193862 | EARLY_PHASE1 | RECRUITING | Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis |
| NCT06751524 | Not specified | AVAILABLE | Expanded Access Program (EAP) Designed to Provide Access to Botensilimab and Balstilimab Before Regulatory Approval |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).
Related Atlas pages
No linked Atlas pages yet — the cross-entity mesh grows as the corpus expands.